Oxycodone And Acetaminophen Tablet
FDA Recall NDC 0406-0522
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Oxycodone And Acetaminophen (NDC 0406-0522). A significant event, classified as Class II, was initiated on Dec 16, 2025 by Specgx Llc. The reported reason for this action was: "Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Dec 16, 2025
Jan 14, 2026
287,988 Bottles.
Recall Profile & Regulatory Data
Event ID
98136
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
SpecGx, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01.
Batch or Lot Expiration Information
Lot# Lot: 0523J23904, expires: 05/2027; 0523J24426, 0523J24427, expires: 06/2027.
Affected Packages Involved in this Recall
0406-0512-01Product
0406-0512-05Product
0406-0512-62Product
0406-0512-23Product
0406-0512-91Product
0406-0522-01Product
0406-0522-62Product
0406-0522-05Product
0406-0522-23Product
0406-0523-01Product
0406-0523-62Product
0406-0523-05Product
0406-0523-23Product
Class II Ongoing
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Dec 16, 2025
Jan 14, 2026
74,544 bottles
Recall Profile & Regulatory Data
Event ID
98136
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
SpecGx, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0522-01. Case label: SpecGx LLC, NDC 0406052201, Exp. 2027/03, Lot: 0522J23493
Batch or Lot Expiration Information
Lot# Lot: 0522J23493, expires: 03/2027.
Affected Packages Involved in this Recall
0406-0512-01Product
0406-0512-05Product
0406-0512-62Product
0406-0512-23Product
0406-0512-91Product
0406-0522-01Product
0406-0522-62Product
0406-0522-05Product
0406-0522-23Product
0406-0523-01Product
0406-0523-62Product
0406-0523-05Product
0406-0523-23Product
0406052201Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
